Aspen API. More than just an API.
01 1Aspen API
02 1Tofigh Daru
03 2Veranova
04 1Malladi Drugs & Pharmaceuticals Limited
05 1Rusan Pharma
06 1Abbott Laboratories
07 1Arevipharma
08 1Boehringer Ingelheim GmbH
09 2Cambrex Corporation
10 1Chattem Chemicals, Inc
11 1Cody Laboratories, Inc.
12 1Curia
13 1Fujifilm Diosynth Biotechnologies
14 1Hasti Aria Shimi
15 1Jiangsu Nhwa Pharmaceutical
16 1Johnson & Johnson Innovative Medicine
17 1Kern Pharma S.L.
18 1Kimyagaran
19 1Maiden Group
20 2Mallinckrodt Pharmaceuticals
21 1Merck & Co
22 1Northern Synthesis
23 1OmnisMed Pharmaceuticals
24 2Pioneer Agro Extracts
25 1Saneca Pharmaceuticals
26 1Yichang Humanwell Pharmaceutical
27 1Blank
01 2China
02 2Germany
03 5India
04 3Iran
05 2Ireland
06 1Latvia
07 1Netherlands
08 1Slovakia
09 1Spain
10 10U.S.A
11 2United Kingdom
12 1Blank
01 5Active
02 9Inactive
03 17Blank
01 12Valid
02 19Blank
01 1218MF10580
02 1226MF10217
03 1229MF10161
04 28Blank
01 1WC-0174
02 1WC-0174a1
03 1WC-0278
04 28Blank
Certificate Number : R1-CEP 2013-071 - Rev 00
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 1103
Status : Valid
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5038
Submission : 1983-08-15
Status : Active
Type : II
Certificate Number : R1-CEP 2005-104 - Rev 04
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 1103
Status : Valid
NDC Package Code : 49812-0001
Start Marketing Date : 1985-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-210-J-918
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Available Reg Filing : ROW |
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Certificate Number : R1-CEP 2016-023 - Rev 00
Issue Date : 2022-05-30
Type : Chemical
Substance Number : 1103
Status : Valid
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
Certificate Number : R1-CEP 2000-303 - Rev 04
Issue Date : 2014-10-13
Type : Chemical
Substance Number : 1103
Status : Valid
NDC Package Code : 49812-0001
Start Marketing Date : 1985-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-210-J-918
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
Available Reg Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20774
Submission : 2007-07-18
Status : Inactive
Type : II
Certificate Number : CEP 2007-208 - Rev 03
Issue Date : 2023-11-03
Type : Chemical
Substance Number : 1103
Status : Valid
Registrant Name : Samung Industrial Co., Ltd.
Registration Date : 2022-02-15
Registration Number : 20220215-210-J-1232
Manufacturer Name : Yichang Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.19, Dalian Road, Yichang Development Zone, Hubei, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19081
Submission : 2006-01-03
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4751
Submission : 1983-01-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7051
Submission : 1987-07-02
Status : Inactive
Type : II
Certificate Number : CEP 2009-097 - Rev 02
Issue Date : 2024-01-30
Type : Chemical
Substance Number : 1103
Status : Valid
Registration Number : 229MF10161
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2017-08-17
Latest Date of Registration : --
NDC Package Code : 0406-1130
Start Marketing Date : 1996-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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